Phthalates and Consumer Goods
Are They Or Aren't They A Concern?

My name is Larry Gayne. I do not have any hidden agenda regarding the use of Phthalate chemicals in PVC, nor have I any axe to grind with the plastics (PVC) suppliers. I am not a chemical engineer. However, I did spend more years in university than I care to mention and I do own an adult toy manufacturing company called Lady Calston. So, I do have sufficient resources and reason to justify some investigation into the possible problems associated with the consumer use of products with Phthalate content.

Firstly, it would probably be most beneficial to define what exactly it is that we are talking about. Phthalates are basically any chemical which is formed by mixing phthalic acid and alcohol. They are an important ingredient in PVC (Poly Vinyl Chloride), a common plastic. They are added to PVC to increase the flexibility. There are 3 groups, Ortho, Iso and Tere, as well as a whole host of sub groups. So, in fact, there are many different types of Phthalates. And, the issue of course , is simply whether or not Phthalates are harmful to people. In order to fully appreciate that issue and hopefully draw some beneficial conclusions we should attempt to understand the depth of Phthalate use in North America.

Phthalates are found in pool liners, car interiors, medical equipment, adhesives, nail polish, sex toys, food containers, virtually any plastic that needs to be soft and pliable. Used in large quantities, due to its low relative cost, they revolutionized an exploding plastics industry after PVC was introduced in the 1950's. Today, well over 1 billion pounds of Phthalates are added to PVC each year in the US alone.

There have been many studies over the past 10-15 years regarding PVC. However, due to the relative large number of different Phthalates available and in use (some 25 are in common use today) and the hugely varying criteria of investigation and analysis, there is little, if any, corroborating research on any given Phthalate.

1) 2000 US Consumer Product Safety Commission completed a multi-year study
and concluded that toys containing DINP were not a health risk to
children. Although they agreed that DNIP could be toxic, they found that
children sucked on toys an average only 1.9 minutes per day and would
have to suck for 39 minutes (per day) to ingest risky levels.

2) 2002 FDA agrees with research results provided by the Cosmetics Ingredient
Review Panel (CIR) which found that Phthalates in cosmetics pose no risk.

3) 2004 After many years of research the EU decides to totally ban 3 specific
Phthalates DEHP, DBP and BBP in children's toys and child care items
and restricts 3 other Phthalates DINP, DIDP and DNOP from use in
children's toys and child care items that children can put in their mouth.

4) 2004 A joint study by the Children's National Medical Center and George
Washington University found no adverse effects in adolescents exposed
to significant quantities of DEHP.

5) 2004 A joint Swedish-Danish research team found a strong link between
allergies in children and the Phthalate DEHP and BBzP.

6) 2005 Dr. Shana Swan publishes the results of her studies and claims that
"Utero exposures to the Phthalates DBP, DEP, BBP, and DEHP, can lead
to birth defects and genital malformations." She concluded that Phthalates
specifically reduced anogenital distance.

7) 2005 A study by the University of Missouri in Columbia reported that DEHP may
mimic the female hormone estrogen and cause "feminisation" of baby boys.

8) 2006 The EU declares DINP and DIDP as "safe" (for adults and infants) in
contradiction to an earlier decision to restrict these same Phthalates
in baby toys and associated products that are put into their mouth.

So clearly, the research to date is all over the board and to such an extent that it appears somewhat inconsistent. To further cloud the issue there is a question of degree. With so little reliable facts, what is considered acceptable levels of exposure or intake of Phthalates? There has obviously been no active research involving the purposeful ingestion of Phthalates by a subject group of humans to determine harm levels. Only passive analysis of humans known to be exposed to surrounding Phthalates has been reviewed. On the other hand, proactive studies using rodents have shown that the ingestion of large amounts of Phthalates does damage to liver, kidneys, lungs and developing testes. The acceptable safety standard to which toxicologists adhere regarding the acceptable level of any given toxin to which a human should be permitted to be exposed is 1,000 times. To the extent that this is a reasonable standard is a matter of conjuncture. It has been confirmed that exposure to 100 milligrams of DBP a day (per kilogram of body weight) will produce adverse effects in rats. Therefore, based upon the 1,000 time rule, humans should not be exposed to more than 0.1 milligram of DBP (per kilogram of body weight) per day to remain "safe". Unfortunately, in 2001 a study by the National Center For Disease Control and Prevention found that the general human population was exposed to 0.2 milligrams of DBP per kilogram of body weight. What's more the agency which set the level of 0.1 milligrams, over a decade ago, states that it is now revising the bar.

Independent tests done by various representatives of the plastics industry both in North America and Europe seem to be in general agreement and do not believe that the public is exposed to unacceptable or harmful levels of Phthalates. Eastman Chemical Company states unequivocally that "Phthalates...have been thoroughly studied over many years, allowing for their widespread and safe use in many types of consumer and health care products." Of course, what else would you expect. The plastic industry is a huge entity generating 350 billion dollars a year and employing 1.5 million people in the US alone. Plus, they have a substantive lobby group to ensure that business remains "as usual". What's more, the EU ban on certain Phthalates may be more of a political response to the recent "mad cow" debacle than to actual scientific evidence. It has been determined by the EU commission that much of the conclusions drawn to justify a ban on certain Phthalates were based on standards of unrealistic proportion. For the purpose of the research, it was assumed that a child could chew a plastic item for up to 12 hours a day. More recent studies have found, in fact, that children suck on toys approximately 2 minutes per day on average. Bill Durodic, Senior Lecturer in Risk and Corporate Security at Cranfield University (UK) believes that "a convergence of social, cultural and political forces were forcing, the agenda and had little to do with any scientific evidence for a ban." In fact, Mr. Durodic recounts that when the first restrictions were introduced, Professor Jim Bridges, Chair of the European Commission's own Scientific Committee on Toxicity, Ecotoxicity and the Environment, sent a note to the Head of the European Commission Directorate for Public Health and Consumer Safety expressing 'very serious concern at the gross misuse' of his Committee's Opinions in seeking to justify a ban.

So, what does all this mean and what is its effect on the adult toy industry in North America? Are our customers in jeopardy? Are we high risk? It has been reliably determined that food (through processing and packaging using plastics) constitutes 85-90 percent of the Phthalate exposure in adults (mostly from meat and fish products). For infants, depending on whether the baby is breast fed or not, the rate is 44-60 percent from food (via food packaging and processing), with the remaining amount in both groups being attributable almost entirely to dust. While long term exposure from adult toys is undoubtedly far lower than the exposure from food, there exists no data whatsoever as to the exposure rate (much less the impact) of our toys to the consumer. Furthermore, our industry is as vulnerable to negative press and government rampaging as is the food industry.

There remains far more questions than reliable answers. For example, which are the real Phthalate culprits? What levels of exposure are acceptable? What are the real risks associated with using adult toys in these regards? There is no question that many of the subject Phthalates are used in our plastics. And, no one in our industry has the resources to adequately research the prevailing issues for a complete and proper determination as the status of real risk. And given the suggestive research to date, there remains a serious consideration of..."What if?"

In conclusion therefore, it is the opinion of this writer that we undertake a conservative and balanced course to deal with the issue. It should be noted that alternative materials are available but at moderate extra costs. It is my suggestion to all those concerned and Calston intends to follow this course of action...that we switch over immediately to these alternative materials that do not have any of the known problem Phthalates nor are they the primary research subject Phthalates. Long term we should move away from Phthalates entirely. We should promote our products as safe and educate our customers accordingly.

It is the writers view that these are not only the most ethical directions to take but the ones most likely to fend off misconceived and unwarranted potential negative perceptions.

Larry Gayne
Calston Industries Inc.